83 FR 46957 - Agency Information Collection Activities; Proposed Collection; Comment Request; Obtaining Information for Evaluating Nominated Bulk Drug Substances for Use in Compounding Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 180 (September 17, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 180 (September 17, 2018)
| Page Range | 46957-46959 | |
| FR Document | 2018-20092 |
[Federal Register Volume 83, Number 180 (Monday, September 17, 2018)] [Notices] [Pages 46957-46959] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-20092] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-2973] Agency Information Collection Activities; Proposed Collection; Comment Request; Obtaining Information for Evaluating Nominated Bulk Drug Substances for Use in Compounding Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with FDA research in obtaining information from medical specialty groups and/or medical experts regarding compounded drug products that contain certain bulk drug substances to support establishment of a list of bulk drug substances under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). DATES: Submit either electronic or written comments on the collection of information by November 16, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of November 16, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2018-N-2973 for ``Obtaining Information for Evaluating Nominated Bulk Drug Substances for Use in Compounding Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected]. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this [[Page 46958]] requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Clinical Use of Bulk Drug Substances Nominated for Use in Compounding by Outsourcing Facilities OMB Control Number 0910--NEW This information collection supports Agency-sponsored research. Section 503B of the FD&C Act requires FDA to develop a list of bulk drug substances that may be used in compounding under that section (503B bulks list). Compounding includes the combining, admixing, mixing, diluting, pooling, reconstituting, or otherwise altering of a drug or bulk drug substance to create a drug. If certain conditions are met, drug products compounded by entities known as outsourcing facilities are exempt from the following requirements of the FD&C Act: Requirements for FDA approval of drugs, labeling with adequate directions for use, and drug supply chain security requirements. Outsourcing facilities can only use a bulk drug substance to compound drugs if: (1) The substance appears on a list developed by FDA of bulk drug substances for which there is a clinical need (``bulks list'') or (2) the substance is used to compound a drug on FDA's drug shortage list at the time of compounding, distribution, and dispensing. Many bulk drug substances have been nominated by the public for use in compounding by outsourcing facilities with adequate supporting information for FDA to evaluate them. The substances were nominated to treat a variety of conditions, ranging in degree of severity from treatment of warts to treatment of cancer. To inform our evaluation of bulk drug substances for inclusion on the 503B bulks list, we have proposed a research study with the University of Maryland (UMD) Center of Excellence in Regulatory Science and Innovation (CERSI) and the Johns Hopkins University (JHU) CERSI. We intend to seek input from the CERSI-UMD on the use of these bulk drug substances in clinical practice by examining their current and historical use in compounding. Information regarding the historical and current use of the substances in compounding obtained by this research will help inform our assessments as to the clinical need for outsourcing facilities to use the substance in compounding. FDA's analysis concerning clinical need of nominated bulk drug substances consists of two parts. The collaboration with CERSI-UMD and CERSI-JHU pertains to part 2 of the analysis, which applies to bulk drug substances that are not components of FDA-approved drug products, as well as certain bulk drug substances that are components of FDA- approved drug products and have successfully completed part 1. One of the factors that FDA considers under part 2 is ``current and historical use of the substance in compounded drug products, including information about the medical condition(s) that the substance has been used to treat and any references in peer-reviewed medical literature.'' As needed, researchers will also engage outsourcing facilities that have compounded using the bulk drug substance. Researchers may use surveys, interviews, focus groups, and other information collect tools, as appropriate, to obtain information concerning the use of compounded product(s) from medical experts and outsourcing facilities. Within this context, the following questions may be posed: 1. What are the health conditions that the compounded drug is currently and has been historically used to treat? What is the patient population for which the compound drug has been used to treat? 2. What are the characteristics of the compounded drugs using the bulk drug substance (e.g., dosage form, strength, route of administration)? 3. Is the compounded drug considered standard therapy by healthcare practitioners, and is it recommended in clinical practice guidelines? If so, under what circumstances? 4. Does an approved drug exist for the health condition that the compounded drug product is used to treat? If so, what are the circumstances under which a compounded drug product using the bulk drug substance would be used in lieu of the approved drug product? 5. What is the historical use of the compounded drug to treat the health conditions identified, including the number of years during which the compounded drug has been prescribed for each use, and any change regarding its use over time? 6. To what extent do practitioners prescribe the compounded drug to treat each health condition identified? How many such prescriptions and/or orders have been written in the past 5 years? Have there been any notable changes in the number of prescriptions and/or orders written over this time? 7. How widespread is the use of the compounded drug product, including use in other countries? 8. Do practitioners order the compounded drug to maintain on hand before a patient presents with a need for the drug (``office stock''), or do practitioners typically write prescriptions for a patient after the patient presents with a need for the compounded drug? If the former, why (e.g., emergency situations, convenience)? 9. What, if any, information exists regarding the effectiveness of the compounded drug product in treating the specified health condition? We estimate the burden of the collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Information collection Number of responses per Total annual Average burden Total hours respondents respondent responses per response -------------------------------------------------------------------------------------------------------------------------------------------------------- Focus groups and interviews........................................ 150 10 1,500 2 3,000 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. [[Page 46959]] We base our estimate of the average burden per response on review activities familiar to the Agency. Noting that 2 hours per response is a significant amount of time, we are particularly interested in feedback regarding this estimate, including comments regarding how an alternative estimate might be derived. Dated: September 11, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-20092 Filed 9-14-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Notices 46957
Authority: Section 1110 of the Social Electronic Submissions submission. You should submit two
Security Act. copies total. One copy will include the
Submit electronic comments in the
Emily B. Jabbour, following way: information you claim to be confidential
ACF/OPRE Certifying Officer. • Federal eRulemaking Portal: with a heading or cover note that states
https://www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
[FR Doc. 2018–20068 Filed 9–14–18; 8:45 am]
instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ The
BILLING CODE 4184–07–P
Comments submitted electronically, Agency will review this copy, including
including attachments, to https:// the claimed confidential information, in
www.regulations.gov will be posted to its consideration of comments. The
DEPARTMENT OF HEALTH AND
the docket unchanged. Because your second copy, which will have the
HUMAN SERVICES
claimed confidential information
comment will be made public, you are
Food and Drug Administration redacted/blacked out, will be available
solely responsible for ensuring that your
for public viewing and posted on
comment does not include any
https://www.regulations.gov. Submit
[Docket No. FDA–2018–N–2973] confidential information that you or a
both copies to the Dockets Management
third party may not wish to be posted,
Agency Information Collection Staff. If you do not wish your name and
such as medical information, your or
Activities; Proposed Collection; contact information to be made publicly
anyone else’s Social Security number, or
Comment Request; Obtaining available, you can provide this
confidential business information, such
Information for Evaluating Nominated information on the cover sheet and not
as a manufacturing process. Please note
Bulk Drug Substances for Use in in the body of your comments and you
that if you include your name, contact
Compounding Drug Products Under must identify this information as
information, or other information that
Section 503B of the Federal Food, ‘‘confidential.’’ Any information marked
identifies you in the body of your
Drug, and Cosmetic Act as ‘‘confidential’’ will not be disclosed
comments, that information will be
except in accordance with 21 CFR 10.20
posted on https://www.regulations.gov.
AGENCY: Food and Drug Administration, and other applicable disclosure law. For
• If you want to submit a comment
HHS. more information about FDA’s posting
with confidential information that you
ACTION: Notice. of comments to public dockets, see 80
do not wish to be made available to the
FR 56469, September 18, 2015, or access
public, submit the comment as a
SUMMARY: The Food and Drug the information at: https://www.gpo.gov/
written/paper submission and in the
Administration (FDA or Agency) is fdsys/pkg/FR-2015-09-18/pdf/2015-
manner detailed (see ‘‘Written/Paper
announcing an opportunity for public 23389.pdf.
Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
comment on the proposed collection of
certain information by the Agency. Written/Paper Submissions read background documents or the
Under the Paperwork Reduction Act of electronic and written/paper comments
Submit written/paper submissions as
1995 (PRA), Federal Agencies are received, go to https://
follows:
required to publish notice in the www.regulations.gov and insert the
• Mail/Hand delivery/Courier (for
Federal Register concerning each docket number, found in brackets in the
written/paper submissions): Dockets
proposed collection of information and heading of this document, into the
Management Staff (HFA–305), Food and
to allow 60 days for public comment in ‘‘Search’’ box and follow the prompts
Drug Administration, 5630 Fishers
response to the notice. This notice and/or go to the Dockets Management
Lane, Rm. 1061, Rockville, MD 20852.
solicits comments on information Staff, 5630 Fishers Lane, Rm. 1061,
• For written/paper comments
collection associated with FDA research Rockville, MD 20852.
submitted to the Dockets Management
in obtaining information from medical Staff, FDA will post your comment, as FOR FURTHER INFORMATION CONTACT:
specialty groups and/or medical experts well as any attachments, except for Domini Bean, Office of Operations,
regarding compounded drug products information submitted, marked and Food and Drug Administration, Three
that contain certain bulk drug identified, as confidential, if submitted White Flint North, 10A–12M, 11601
substances to support establishment of a as detailed in ‘‘Instructions.’’ Landsdown St., North Bethesda, MD
list of bulk drug substances under Instructions: All submissions received 20852, 301–796–5733, PRAStaff@
section 503B of the Federal Food, Drug, must include the Docket No. FDA– fda.hhs.gov.
and Cosmetic Act (FD&C Act). 2018–N–2973 for ‘‘Obtaining SUPPLEMENTARY INFORMATION: Under the
DATES: Submit either electronic or Information for Evaluating Nominated PRA (44 U.S.C. 3501–3520), Federal
written comments on the collection of Bulk Drug Substances for Use in Agencies must obtain approval from the
information by November 16, 2018. Compounding Drug Products Under Office of Management and Budget
ADDRESSES: You may submit comments Section 503B of the Federal Food, Drug, (OMB) for each collection of
as follows. Please note that late, and Cosmetic Act.’’ Received comments, information they conduct or sponsor.
untimely filed comments will not be those filed in a timely manner (see ‘‘Collection of information’’ is defined
considered. Electronic comments must ADDRESSES), will be placed in the docket in 44 U.S.C. 3502(3) and 5 CFR
be submitted on or before November 16, and, except for those submitted as 1320.3(c) and includes Agency requests
2018. The https://www.regulations.gov ‘‘Confidential Submissions,’’ publicly or requirements that members of the
electronic filing system will accept viewable at https://www.regulations.gov public submit reports, keep records, or
comments until midnight Eastern Time or at the Dockets Management Staff provide information to a third party.
daltland on DSKBBV9HB2PROD with NOTICES
at the end of November 16, 2018. between 9 a.m. and 4 p.m., Monday Section 3506(c)(2)(A) of the PRA (44
Comments received by mail/hand through Friday. U.S.C. 3506(c)(2)(A)) requires Federal
delivery/courier (for written/paper • Confidential Submissions—To Agencies to provide a 60-day notice in
submissions) will be considered timely submit a comment with confidential the Federal Register concerning each
if they are postmarked or the delivery information that you do not wish to be proposed collection of information
service acceptance receipt is on or made publicly available, submit your before submitting the collection to OMB
before that date. comments only as a written/paper for approval. To comply with this
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![Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Notices 46959
We base our estimate of the average Dated: September 11, 2018. The committee shall consist of a core
burden per response on review activities Leslie Kux, of 13 voting members including the
familiar to the Agency. Noting that 2 Associate Commissioner for Policy. Chair. Members and the Chair are
hours per response is a significant [FR Doc. 2018–20091 Filed 9–14–18; 8:45 am] selected by the Commissioner or
amount of time, we are particularly BILLING CODE 4164–01–P designee from among authorities
interested in feedback regarding this knowledgeable in the fields of general
estimate, including comments regarding oncology, pediatric oncology,
how an alternative estimate might be DEPARTMENT OF HEALTH AND hematologic oncology, immunology
derived. HUMAN SERVICES oncology, biostatistics, and other related
Dated: September 11, 2018. professions. Members will be invited to
Food and Drug Administration serve for overlapping terms of up to 4
Leslie Kux,
[Docket No. FDA–2018–N–3236] years. Almost all non-Federal members
Associate Commissioner for Policy.
of this committee serve as Special
[FR Doc. 2018–20092 Filed 9–14–18; 8:45 am]
Advisory Committee; Oncologic Drugs Government Employees. The core of
BILLING CODE 4164–01–P voting members may include one
Advisory Committee; Renewal
technically qualified member, selected
AGENCY: Food and Drug Administration, by the Commissioner or designee, who
DEPARTMENT OF HEALTH AND HHS.
is identified with consumer interests
HUMAN SERVICES ACTION:Notice; renewal of advisory and is recommended by either a
committee. consortium of consumer-oriented
Food and Drug Administration
SUMMARY: The Food and Drug organizations or other interested
Administration (FDA) is announcing the persons. In addition to the voting
[Docket No. FDA–2018–N–3431]
renewal of the Oncologic Drugs members, the committee may include
Anesthetic and Analgesic Drug Advisory Committee by the one non-voting member who is
Products Advisory Committee; Notice Commissioner of Food and Drugs (the identified with industry interests.
of Meeting; Establishment of a Public Commissioner). The Commissioner has Further information regarding the
Docket; Request for Comments; determined that it is in the public most recent charter and other
Correction interest to renew the Oncologic Drugs information can be found at https://
Advisory Committee for an additional 2 www.fda.gov/AdvisoryCommittees/
AGENCY: Food and Drug Administration, years beyond the charter expiration CommitteesMeetingMaterials/Drugs/
HHS. date. The new charter will be in effect OncologicDrugsAdvisoryCommittee/
until September 1, 2020. ucm107395.htm or by contacting the
ACTION: Notice; correction. Designated Federal Officer (see FOR
DATES: Authority for the Oncologic
Drugs Advisory Committee will expire FURTHER INFORMATION CONTACT). In light
SUMMARY: The Food and Drug on September 1, 2020, unless the of the fact that no change has been made
Administration is correcting a notice Commissioner formally determines that to the committee name or description of
entitled ‘‘Anesthetic and Analgesic Drug renewal is in the public interest. duties, no amendment will be made to
Products Advisory Committee; Notice of 21 CFR 14.100.
FOR FURTHER INFORMATION CONTACT:
Meeting; Establishment of a Public This document is issued under the
Lauren Tesh, Center for Drug Evaluation
Docket; Request for Comments’’ that Federal Advisory Committee Act (5
and Research, Food and Drug
appeared in the Federal Register of U.S.C. app.). For general information
Administration, 10903 New Hampshire
September 11, 2018. The document related to FDA advisory committees,
Ave., Bldg. 31, Rm. 2417, Silver Spring,
announced a forthcoming public please check https://www.fda.gov/
MD 20993–0002, 301–796–9001, email:
advisory committee meeting of the AdvisoryCommittees/default.htm.
ODAC@fda.hhs.gov.
Anesthetic and Analgesic Drug Products Dated: September 11, 2018.
SUPPLEMENTARY INFORMATION: Pursuant
Advisory Committee and establishment
of a public docket for comments. The to 41 CFR 102–3.65 and approval by the Leslie Kux,
document was published with the Department of Health and Human Associate Commissioner for Policy.
Services pursuant to 45 CFR part 11 and [FR Doc. 2018–20108 Filed 9–14–18; 8:45 am]
incorrect docket number. This
by the General Services Administration,
document corrects that error. BILLING CODE 4164–01–P
FDA is announcing the renewal of the
FOR FURTHER INFORMATION CONTACT: Lisa Oncologic Drugs Advisory Committee.
Granger, Office of Policy and Planning, The committee is a discretionary DEPARTMENT OF HEALTH AND
Food and Drug Administration, 10903 Federal advisory committee established HUMAN SERVICES
New Hampshire Ave., Bldg. 32, Rm. to provide advice to the Commissioner.
3330, Silver Spring, MD 20993–0002, The Oncologic Drugs Advisory Food and Drug Administration
301–796–9115. Committee advises the Commissioner or
[Docket No. FDA–2018–N–0001]
designee in discharging responsibilities
SUPPLEMENTARY INFORMATION: In the as they relate to helping to ensure safe
Federal Register of Tuesday, September Pathogen Reduction Technologies for
and effective drugs for human use and, Blood Safety; Public Workshop
11, 2018 (83 FR 45941), in FR Doc. as required, any other product for which
2018–19667, on page 45941, the FDA has regulatory responsibility. AGENCY: Food and Drug Administration,
daltland on DSKBBV9HB2PROD with NOTICES
following correction is made: The committee reviews and evaluates HHS.
On page 45941, in the first column, in data concerning the safety and ACTION: Notice of public workshop.
the header of the document, and also in effectiveness of marketed and
the third column under Instructions, investigational human drug products for SUMMARY: The Food and Drug
‘‘Docket No. FDA–2018–N–3276’’ is use in the treatment of cancer and Administration (FDA) is announcing the
corrected to read ‘‘Docket No. FDA– makes appropriate recommendations to following public workshop entitled
2018–N–3431’’. the Commissioner. ‘‘Pathogen Reduction Technologies for
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Document Created: 2018-09-15 01:37:37
Document Modified: 2018-09-15 01:37:37
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on the collection of information by November 16, 2018. | |
| Contact | Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected] | |
| FR Citation | 83 FR 46957 |
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